Monday, July 26, 2021

TUMOR DETECTION FOR DENSE BREASTS

BREAST CANCER DECODED  By: Robert L. Bard, MD

  


CONCEPT AND APPROACH

Drastic changes in the incidence, diagnosis and treatment of breast cancer and benign breast disease highlight a singular need for an up to date source on the early detection and proper therapy of breast tumors.  The age of occurrence of breast cancer, formerly only a problem of older women, is now at a median age of 45 years.  This means that women in their twenties are developing breast cancer.  Although risk factors have been identified, the jeopardy to life is unchanged.  The increasing use of estrogen for osteoporosis and other female disorders may elevate the risk of breast cancer.  One out of every eight women will develop breast cancer.  Fortunately, the vast majority of tumors in younger women are benign and can be diagnosed by simple, safe non surgical tests.  Jewish women, prone to breast cancer, are further plagued by the concomitant presence of fibrocystic breasts that are lumpy and mask a growing breast cancer.


The incidence of miss by mammography increases markedly in younger patients and those with "mastitis" or "cystic" breasts.  A paper from the University of Indiana Medical Center on the mammographic diagnosis of fibroadenomas (benign tumor of young women) demonstrated that in 35 surgically proven biopsies, the mammogram missed every mass. A non x ray exam, called the sonogram, was able to diagnose every tumor in this study. Another non-x ray test, called Doppler ultrasound, according to DIAGNOSTIC IMAGING (1988) and CLINICAL RADIOLOGY (1990) may detect breast tumors not seen by all other tests. Light scanning is another procedure that uses computers and fiberoptics to visualize tumors.

The latest text book on Breast Disease, BREAST ULTRASOUND by Thomas Stavros (Lippincott, 2002) mentioned that most abnormalities of the breast may be better characterized or even detected only by diagnostic ultrasound procedures. JAMA (May 1993) noted mammography readings were highly variable with many false positives. Moreover, one expert missed 67% of cancers on high quality mammograms. Indeed, top mammographers disagreed clinically in 1/3 of readings.

 Since cancers may lie dormant for up to ten years and that mammography is less accurate in younger women, one realizes that sonography becomes necessary for a complete workup in the detection of invasive. Mayo Clinic computer program shows sonograms capable of 99% accuracy. The latest malpractice newsletters warn physicians that they are liable if they miss a breast cancer because they have not performed a sonogram. In fact, the PIAA Data Sharing Report shows that the patient found the tumor in 69% of cases, mammography missed or was equivocal in 49% and the median age of breast cancer was 43 years of age. False negatives were highest in the under age 40 group comprising 40% of claims.

 

BREAST IMPLANTS                

Every year over 150,000 women have breast implants. Recent press has pointed to the problem of breast cancer development in the augmented breast and the inability of mammography to see it.

Mammography has also long been used as the primary diagnostic imaging study for complications of breast augmentation in the over one million women who currently have breast implants. However, lack of accuracy of both mammographic information and clinical interpretation have necessitated the application of the non x ray imaging modalities of light scanning, sonography and duplex Doppler ultrasound.

Every plastic surgeon has received a radiologist's mammogram report on a patient in whom a long standing implant has been removed for various complications that referred to the ovoid shaped density as a "prosthesis in position."  Radiographically, the hard capsule that forms after a year cannot be differentiated from certain implant devices. Also, a leakage of silicone gel that is restricted to the fibrous capsule is not separately distinguishable. Thus, x rays are inadequate for the diagnosis of implant rupture except where the silicone has extruded physically through the capsule. Even then, the routine views may not demonstrate leakage that is close to the surface of the capsule so that it will only be identified by a tangential x ray beam. An irregular outline of an implant may be positional, caused by adjacent breast pathology, resultant of fibrous septation or actually due to implant rupture.

A sonogram identifies an implant much the same as a cyst. Thus the size, shape, position, peripheral envelope, wall contour and internal echo pattern are readily demonstrable. Rupture of an implant, whether from structural failure, interoperative damage, penetrating trauma or blunt trauma such as closed capsulotomy, is quickly and accurately diagnosed by routine high frequency sonography.

Sonography is also important in breast cancer diagnosis since the implant masks most of the breast from the x ray. Dr. Levine, in the 1990 article: DEFINITIVE DIAGNOSIS OF BREAST IMPLANT RUPTURE BY ULTRASONOGRAPHY in "Plastic and Reconstructive Surgery" states that sonography is the best imaging modality for the augmented breast.

Perhaps more interesting are the roles of light scanning and duplex Doppler imaging in the diagnosis of the cause of the implant rupture. Spontaneous failure of the envelope will be accompanied by fluid extravasation. If recent and localized, light scanning and Doppler flows will be unremarkable. A long standing leakage may become secondarily infected, thus producing unilateral light absorption. Similarly, trauma, intraoperative or external, may be associated with bleeding which will also absorb light rays. Thus, a normal light scan exam in transillumination suggests the probability of structure failure of the implant. Duplex Doppler may shows linear fluid filled structures to be adjacent arteries or veins. Additionally, this procedure may detect cancers adjacent to the implant.

 The treatment of breast disease has also changed from the days of deforming radical mastectomies.  Simple removal of the tumor followed by mastectomy, chemotherapy and radiation therapy are now available.  Post mastectomy reconstructive surgery will often restore a woman to her former natural shape.  In England and Australia, where breast ultrasound and Doppler analysis are routinely used, exploratory surgery has decreased 90%.  The American Cancer Society stresses self examination and mammography.  Unfortunately, the survival rate of breast cancer has not changed in the past 25 years.  Clearly, other diagnostic exams are needed, since the cure rate is related to the early detection of the disease. Alarmingly, despite many years of ongoing, improved and massive breast cancer screening, the US National Center for Health Statistics now sates that the incidence of number of cases of this disease is actually increasing.

 Many women are overwhelmed with the variety of medical tests and their safety. Recent articles in the NY Times stated that the female patient is psychologically ill equipped to deal with the emotional trauma of breast cancer at the time of diagnosis. These reports suggest that women be well informed prior to the discovery of a tumor, so that they may make a better informed decision.  The book addresses the specific type of exam for both early detection of breast disease as well as the optimal test for specific disorders for each individual woman in an orderly, sequential and safe format.  The pro's and con's of treatment protocols are also formatted.  The author, a radiologist specializing in new methods of breast imaging, has been lecturing for the Ultrasonic Institute on new methods of breast cancer detection since 1973 at medical centers around the nation and at international conferences and mentions in this book all types of exams and therapies.  The reader chooses for herself what modality may be most suitable.  Methods used in Europe, for example, find acceptance in American medicine twenty or thirty years later.  Some medical regimens may be generally unsuitable for patients, yet may be ideal or the only possibility for an individual woman.  Diagrams of the various exams are available for better appreciation of the visually oriented test.  As a ready reference format, each chapter is preceded by a one page summary for quick review.  The overall aim of the work is to be a health "bible" for breast disorders for the 1990's woman.  

It is obvious that too few women are getting the message about the importance of early breast cancer detection since they fear that it will be too late or the therapy will be too deforming.  The purpose of the book is to show that CHANCES ARE ITS BENIGN, AND, PROPER TREATMENT CAN SAVE YOUR LIFE AND NOT DISFIGURE.  The work reaches out to the reader to reassure her with dramatic evidence that taking control of her breasts' health in a planned, stepwise manner can mean the difference between the words:  "The scan shows it's a cyst.  Don't worry" and the chilling sentence, "we could have helped you if you come in earlier."  Women walk out of my office, knowing that their lump is benign and that their fears are nothing, looking ten years younger.  

Women with cancer can be helped because of the simple techniques used when tumors are small.  Even men develop breast cancer at a rate approximately 1% that of women. Most women do need to know that CHANCES ARE ITS BENIGN.  Since the age range of breast cancer is now from the teens to the hundred's, women of all ages need to become actively involved in managing their health just as they do their finances. Since all women are at risk of breast cancer, all families must know the facts and the choices involved. Jewish women, successful women, women on hormones, women with breast implants and the growing number of health conscious people of all ages will want to know thee available regimens so they have the data necessary to knowledgeably take charge of the their own lives.

 

REVIEW OF CURRENT MEDICAL LITERATURE 

Fleisher's DIAGNOSTIC SONOGRAPHY (Saunders 1989) states that a sonogram is the best method for diagnosing benign disorders and that a mammogram is the better tool for diagnosing malignant diseases. He quotes the sensitivity of sonograms in cancer detection at 69% as compared to the mammographic detection rate at 74%. The author's own series using a hand held real time unit (same as Dr. Bard's) shows an accuracy in detecting palpable lesions of 85% for sonograms and 70% for mammograms. Both modalities yield a rate of 89% and he recommends both tests be used in combination.

Hagen-Ansert's TEXTBOOK OF DIAGNOSTIC ULTRASOUND (Mosby 1989) states sonogram is clinically useful in a) dense breasts  b) younger patients  c) uncertain mammographic findings  d) pregnant patients   e) implants  f) differentiation of cystic from solid in a known mass

Kopan's BREAST IMAGING (Lipincott 1989) states that sonography should not be used for cancer screening. However, he quotes studies by Sickle's, Cole, and Egan showing respectively that sonogram detects cancers at the following rates: 58%, 78% and 79% in the general population 

Britton's article in CLINICAL RADIOLOGY (1990) demonstrates duplex doppler having a sensitivity of 91% and specificity of 89%.

Levin's paper in PLASTIC AND RECONSTRUCTIVE SURGERY (1991) mentions that mammography is unreliable in the post augmented breast and that ultrasonography is the test of choice for evaluation of breast prostheses.

Dixon's paper in BRITISH J SURGERY (1992) showed 78% sensitivity and 100% specificity for carcinoma using duplex Doppler.

Adler’s abstract in ULTRASOUND MED BIOL (1990) has 82% detection rate of malignant neovascularity with duplex Doppler. 

Scatarige's note in THORACIC RADIOLOGY (1989) shows high accuracy of staging internal mammary lymphadenopathy.

Jones review in CLINICAL ONCOLOGY (1990) had sonograms picking up axillary nodes missed by other methods in 27% of cases.

Levin's paper in PLASTIC AND RECONSTRUCTIVE SURGERY (1991) mentions that mammography is unreliable in the post augmented breast and that ultrasonography is the test of choice for evaluation of breast prostheses.

Parker's lecture at the NYU BREAST CANCER UPDATE (1993) showed sonography's ability to detect unsuspected cancers as small as 0.4 cm and determine whether the associated lymphadenopathy was malignant or benign. Mendellson's 1992 talk at DOWNSTATE MEDICAL CONFERENCE showed sonograms to be able to discover occult lesions.

Barth's 1993 study showing sonograms detected more than twice as much multicentric breast cancer than mammography.

Stavro's 1997 paper shows accuracy in detecting benign disease solely by ultrasound at 99.7 %.

Bard's paper in 1993 NY STATE JOURNAL OF MEDICINE revealing mammographic misses in breast implant imaging.

Bard's 1994 lecture at the MAYO CLINIC highlighted the accuracy of multimodality imaging.

Bard's 1996 FEMALE PATIENT paper showed 99% accuracy in benign disease diagnosis                           

 

CONCLUSION

As breast cancer strikes younger women due to lowering of the median age of occurrence, screening procedures become imperative.

Although mammography is the only generally accepted screening modality, it is clearly of limited use in younger patients or those with fibrocystic breasts.  The inaccuracy of sonograms is true if one considers the total population to be screened will predominate in older age groups. Kopan's, in his textbook, admits that he chooses to do sonograms on women under 28 because of anecdotal evidence that it works best. Dr. Bard's suggestion is that sonograms be the screening procedure of choice in younger women and those with fibrocystic breasts. Mammography should remain the gold standard in women over 40 or those with fatty breasts of any age. The combination of light scanning, Doppler ultrasound and standard sonograms of the breast often mean the difference between delayed diagnosis and immediate surgery. Multimodality imaging, the emphasis of this book, offers the patient the difference between weeks of worry for the mammogram to be repeated for "interval change" or for an immediate answer that the problem is benign.

 

 COMPETITION

Aside from a few books on cancer and women's diseases, there are no non-medical books on the spectrum of new tests and therapies for breast disease.  Given the epidemic proportions of breast cancer, the time is right for a new and comprehensive manual for today's concerned and aware women.

Books on personal health include THE DOCTOR BOOK, by Wesley Smith (Price Stern Sloan, L.A. 1987) which has one paragraph on breast exam by a physician and one paragraph on mammography. 

 

The NY TIMES GUIDE TO PERSONAL HEALTH by Jane Brody (Avon, 1982) has 7 pages on breast cancer with 2 paragraphs on diagnostic tests. 

HORMONES, by Lois Jovanovic, MD (Fawcett, 1987) includes 26 pages on breast disease, mentioning the fact that 90% of breast cancers are detected by women themselves, leaving the reader to wonder at the value of the "gold-standard" exams  of mammography and 2 pages on hormone therapy for breast cancer. 

 

CHOICES, by Marion Morra and Eve Potts (Avon 1987) also titled:  Realistic alternatives in cancer therapy, has one chapter on breast cancer, with 6 pages on mammography, one paragraph each on ultrasound, computed tomography, transillumination and thermography.  There are 16 pages on surgery and radiotherapy and 29 pages on post operative care.

 Lauersen's IT'S YOUR BODY (Berkely 1983) on p.418 states that sonograms will be effective in the future. Indeed, Dr. Lauersen routinely now performs sonography on his patients semiannually or more often in his private office.

Gross's WOMEN TALK ABOUT BREAST SURGERY (Harper 1991) has 2 pages mentioning a particular cancer was missed by mammogram and sonogram.

Levy's YOUR BREASTS (Noonday 1990) says one 1 page that benign cysts that are not palpable or show on x ray may be imaged with sonograms.

Thompson's EVERY WOMAN'S HEALTH (Prentice Hall 1990) says on one page that sonograms are useful in cyst detection.

Better Homes and Garden's FAMILY MEDICAL GUIDE (1989) mentions that sonogram is useful if mammography is unclear.

Harvard's YOUR GOOD HEALTH (HARVARD 1987) says on one page that sonogram is good for cyst detection.

Love's DR. SUSAN LOVE'S BREAST BOOK (ADDISON WESLEY 1990) has one half page each on sonogram and transillumination.

Hirshaut's BREAST CANCER: THE COMPLETE GUIDE (BANTAM 1992) has one half page each on sonogram and transillumination.

Many private practice radiologists are currently routinely screening women with cystic breasts or those under fifty with sonograms even though the American College of Radiology does not recognize this as a screening tool. However, there is no other acceptable alternative choice for the patient or better diagnostic tool for the physician other than the non specific MRI exam. Every finding (30% specificity) must be biopsied to be verified.

Wednesday, July 7, 2021

Ultrasound Significantly Reduces False Readings of DENSE BREASTS




TRIBUTE TO A GLOBAL CRUSADER
(Play Video-L) The NY Cancer Resource Alliance gives loving tribute to Dr. Nancy Cappello, co-founder of "Are You Dense" and chief crusader of the mission to bring change to the protocols and standards of Early Detection.   Her organization embarked in a global advocacy project to win legislation for dense breast scanning and to bring awareness to the need for better technologies and imaging interpretation. Today, her loving husband Joe continues her unending fight to save more lives through awareness, advocacy and her crusade for change.  (Also see below to read her full story in our ORG SPOTLIGHT section)


7/8/2021- A wave of recognized medical sites, journals and reports  are now indicating that dense breast tissue increases the risk of developing breast cancer and often masks a tumor from being seen on the mammogram since dense tissue is white and cancerous tissue is also white. Mammograms are the standard screening test for breast cancer, however, in the 21st Century, ultrasound non invasive imaging is the preferred exam for dense “lumpy” mammary disease.   

The 1st World Conference of Breast Ultrasound in Philadelphia (1979) recognized ultrasound superiority in dense breast diagnostics but the density level was never quantified until recently. Mammography assessment of breast density is graded into four categories. Mammographers readily admit that these levels are subjective at best and technical factors such as mammary tissue compression and x-ray voltage/amperage dramatically influence the darkness or whiteness of the image.

What Does It Mean to Have Dense Breasts?


A mammogram shows how dense your breasts are. When you get the results of your mammogram, you may also be told if your breasts have low or high density. Women with dense breasts have a higher risk of getting breast cancer.


















PARTS OF THE BREAST
A woman’s breast has three kinds of tissue: FIBROUS TISSUE holds the breast tissue in place.  GLANDULAR TISSUE is the part of the breast that makes milk, called the lobes, and the tubes that carry milk to the nipple, called ducts. Together, fibrous and glandular tissue are called fibroglandular tissue.  FATTY TISSUE fills the space between the fibrous tissue, lobes, and ducts. It gives the breasts their size and shape.

BREAST CANCER RISK: Women with dense breasts have a higher chance of getting breast cancer. The more dense your breasts are, the higher your risk. Scientists don’t know for sure why this is true. Breast cancer patients who have dense breasts are not more likely to die from breast cancer than patients with non-dense (fatty) breasts.



URGENCY IN THE EVOLUTION OF TECHNOLOGY & IMAGING STRATEGIES FOR DENSE BREASTS

Written by: Dr. Robert L. Bard

Decades since the advent of breast scanning technology, innovations in non-invasive diagnostic imaging provide new options in the field of early detection. These technologies directly align with breast density screening (and are part of the Bard Breast Density Diagnostic Program) include:

• Doppler blood flow
• Contrast enhanced ultrasound vascularity 
• 3D Vessel Density Histogram 
• 4D Volumetric Density Histogram
• Strain and shear wave tissue Elastography 
• 3 T MRI 
• Optical Computed Tomography (OCT) for nipple lesions
• Reflectance Confocal Microscopy (RCM)  for dermal invasion
• Hybrid Mammo Imaging Fusion
 Thermo-sensor
 Trans Illumination
 Near Infrared Specroscopy

Hybrid imaging refers to combining diagnostic modalities to assess disease and monitor therapy. A useful combination of options is the tumor vessel flow density to assess aggression and treatment progress. Similarly, tissue elastography is useful for border detection of malignant masses.








4D VOLUMETRIC DENSITY HISTOGRAM
This new variation of the 4D ultrasound imaging involves real time scanning of the entire breast and focusing of the greatest density tissue with 3D volumetric capture of the tissue. The computer searches the gray level of the images under study and provides a percentage (%) number of the whiteness of the volume under study.

This investigative process began in 2017 under a study of scar tissue and presented at the 2018 ASLMS meeting using elastography and volumetric sonogram density analysis. Breast cancers, like scar tissue, are dark while fibrocystic abnormal tissues is more white.

The clinical utility of 4D image acquisition is:

1. Automated electronics sampling of the tissue volume in real time

2. 200-300 images of a data set are generated in 5-15 seconds

3. The process is User-INDEPENDENT unlike standard 2D ultrasound which is highly user dependent

4. The data set for serial studies uses fixed parameters so that treatment efficacy may be rapidly compared 



INNOVATIONS REFLECTING A NEW IMAGING STRATEGY: MEET THE ABUS
The medical imaging and cancer communities are now taking strides toward the dedicated scanning of Dense Breasts.  As mammograms have been known to have difficulty seeing tumors through dense breast tissue, the demand to upgrade imaging standards is at its highest. Dense breasted patients carry the risk of a mis-read which may miss advanced cases of breast cancer.  

According to GE Healthcare, "Approximately 40% of women have dense breasts, one of the strongest common risk factors for developing breast cancer.  Having dense breasts increases a woman's chance of developing breast cancer by four to six times, and seventy-one percent of breast cancers are found in dense breasts.

Clinical evidence is growing about the effectiveness of ultrasound for finding small, node-negative, invasive cancers missed by mammography. In 2018, GE Healthcare launched the Invenia automated breast ultrasound (ABUS) 2.0 system in the U.S. This FDA Approveed ultrasound supplemental breast screening technology specifically designed for detecting cancer in dense breast tissue. When used in addition to mammography, Invenia ABUS can improve breast cancer detection by 55 percent over mammography alone. Invenia ABUS 2.0 supplemental imaging is designed for the screening environment, specifically for dense breast imaging. Invenia ABUS 2.0 diminishes operator variability and creates 3D ultrasound volumes to enable comprehensive analysis and comparison to multimodality exams. [1]

“We believe ABUS can help clinicians find significantly more cancers than mammography alone, especially in women with dense breasts,” said Luke Delaney, general manager of Automated Breast Ultrasound at GE Healthcare. “As breast ultrasound technology continues to advance, we are investing to continually improve image quality, workflow and patient comfort - all of which contribute to early detection and improved outcomes.” [1]


Dense Breasts: Answers to Commonly Asked Questions 

Q: How common are Dense Breasts?
A: Nearly half of all women age 40 and older who get mammograms are found to have dense breasts. Breast density is often inherited, but other factors can influence it. Factors associated with lower breast density include increasing age, having children, and using tamoxifen. Factors associated with higher breast density include using postmenopausal hormone replacement therapy and having a low body mass index.

Q: Are dense breasts a risk factor for breast cancer?
A: Yes, women with dense breasts have a higher risk of breast cancer than women with fatty breasts, and the risk increases with increasing breast density. This increased risk is separate from the effect (false negatives) of dense breasts on the ability to read a mammogram.



ORG SPOTLIGHT:

“ARE YOU DENSE”- FORGING A SMART, NEW PROTOCOL IN BREAST CANCER SCREENING

By: Joe Cappello of “Are You Dense” (areyoudense.org & areyoudenseadvocacy.org) | Edited by: Carmen R. DeWitt

Dr. Nancy Cappello's Story: "I have dense breast tissue – and women like me (2/3 of pre-menopausal and 1/4 of post menopausal) have less than a 48% chance of having breast cancer detected by a mammogram. In November 2003 I had my yearly mammogram and my "Happy Gram" report that I received stated that my mammogram was "NORMAL" and that there were "no significant findings." Six weeks later at my annual exam in January, my doctor felt a ridge in my right breast and sent me for another mammogram and an ultrasound. The mammogram revealed "nothing" yet the ultrasound detected a large 2.5 cm suspicious lesion, which was later confirmed to be stage 3c breast cancer, as the cancer had metastasized to 13 lymph nodes.... Since then, I learned that there are many women like me with recent normal mammogram reports with a hidden intruder stealing their life.  I am on a quest to expose this best-kept secret of dense breast tissue to ensure that women with dense breast tissue receive screening and diagnostic measures to find cancer at its earliest stage - isn't that the purpose of Screening Programs?"

Nancy's story is a widely common one, and demands to be recognized to change the current standards.  We established an advocacy group to help create a new standard protocol for diagnosis because the current standard is clearly an injustice to ALL women. This includes public education and awareness for the many women who get side swiped because of a lack of understanding and clinical information. 

Our advocacy work led us to reach out to our legislators, explore the current insurance coverages and eventually got our first win with a disclosure law in 2009, making Connecticut the first state in the nation to pass legislation making it a law for Docs to disclose to the patient if they have dense breast tissue.   This says that if a woman has dense breasts, she'd must be told by her physician that she's got dense breast there's alternative screening. This includes options like an ultrasound or an MRI.  Also, two years ago, ‘Are You Dense Advocacy, Inc.’ was instrumental in passing the first national dense breast disclosure law. We are now working with Sen. Feinstein to enact this legislation.  

FORGING A NATIONAL MOVEMENT
 
It used to be that when you Googled ‘dense breast’, there was next to NO information available. But over time, as we started making ‘noise’ about this issue, more and more interest began coming our way.  As news broke of our ‘touchdown’ with our state, it wasn’t long before other states started asking how we did it. Before long, Nancy started helping women across the country and the next state was Texas. She helped the girl down in Texas to get legislation passed – and next came our public educational website for the many others who definitely need this.

Nancy quit her job with the state of Connecticut and started doing “Are You Dense” full-time and she helped pass 38 different laws in 38 states.  It's a tremendous amount of work to pass laws on a state by state basis, but she was really the catalyst. Nancy was the person behind and the voice and the face behind dense breast tissue. As outreach work goes, we created a major effort around what we've done now.  Manufacturers are supporting our interest as far as the expansion of full breast automated ultrasound and others came into existence (and are doing quite well) because of our efforts.

* For more information about Nancy and Joe Cappello's national mission, visit: areyoudense.org and areyoudenseadvocacy.org


From the Surgical Side...
"THEY MADE A LAW REQUIRING DENSE BREAST SCANNING"

In New Jersey, we have the Breast Density Law that literally says women with very dense breasts should be getting more than just screening mammography and the insurance companies have to cover. And that can either be an ultrasound or an MRI, but women over 40 do not usually like the idea of getting an MRI and gadolinium IV each year. Instead, adding ultrasound allows you to scan the whole breast and see through the very dense breast tissue. Ultrasounds will also work to the full depth of the breath straight down to the chest wall, so that if there are any masses,  it will see right through the fibers and thick tissue- not limited like mammogram. 

Even extremely dense breast patients should get a mammogram because it also shows things like calcifications-- something that the average ultrasound tech may find harder to capture. Women with extremely dense breast definitely can benefit from added surveillance because as your breasts get more dense, mammography can miss things.  Due to a higher volume of dense tissue, a little tumor can hide underneath fibercystic tissue making it very hard to see in mammography, even with tomosynthesis or the 3d mammo. 

By: Dr. Stephen Chagares | https://www.drchagares.com


TREATMENT OPTIONS
Risk stratification is important since the cost/benefit of any therapy must be weighed against the likelihood of health consequences. Hormone treatments have been controversial for 50 years and remains so to date. Since Dr. Selig Strax (my late partner) developed the “lumpectomy” for conservative therapy of breast cancer at Mt Sinai Medical Center in the 1960’s, advances in limiting tissue damage have yielded progress in chemotherapy, radiation therapy and immunotherapy. Similarly focal treatment options that began with prostate cancer in 2000 with HIFU (High Intensity Focused Ultrasound) are now found in thyroid and breast treatment centers and Laser Ablation and Cryo Ablation are now available alternatives. 

Elastography is used worldwide since 2010 for cancer detection because cancer is hard (inelastic) and benign tissue is soft (elastic).  This quantitative technology for cancer detection has not been adapted for breast density analysis to date.


REFERENCES

1) GE.com/ Setting A New Standard for Breast Care: GE Healthcare Introduces Invenia ABUS 2.0  https://www.ge.com/news/press-releases/setting-new-standard-breast-care-ge-healthcare-introduces-invenia-abus-20#_ftn1

1) Breast density and risk- European Radiology 31:4839-4847, 2021

2) 4D histogram analysis of malignancy-  Mt Sinai Surgical Symposium  2020- 3D/4D breast density histogram
3) Proceedings: Male Breast Cancer Coalition 2019
4) Ultrasound imaging of subdermal pathology /Springer Heidelberg  2018
5) 3D Doppler imaging of malignant melanoma- Intl Dermatologic Surgery Symposium  2016
6) 3D Doppler imaging in dense breasts Proceedings:  2012 Societe Francaises de Radiologie



CONTRIBUTORS

DR. ROBERT L. BARD has paved the way for the diagnostic study of various cancers both clinically and academically. He runs an active NYC practice (Bard Diagnostic Imaging) using the latest in digital Imaging technology which has been also used to help guide biopsies and, even replicate much of the same reports of a clinical invasive biopsy. Imaging solutions such as high-powered Sonograms, Spectral Doppler, sonofluoroscopy, 3D/4D Image Reconstruction and the Spectral Doppler are safe, noninvasive, and does not use ionizing radiation. His commitment to lead the community of cancer imaging and diagnostic experts has led to the establishment of the "Get Checked Now!" campaign.

JOSEPH J. CAPPELLO married Nancy Marcucci, in 1974 and the story began.  Joe is the co-founder and executive director of Are You Dense, and Are You Dense Advocacy- in January of 2019 after Nancy’s passing from treatment related bone marrow cancer (MDS). His passion is to continue Nancy’s legacy by pursuing the goal that they set in 2004; that not one woman would die from a late stage breast cancer due to dense breast tissue. In 2009, Joe and Nancy championed the first in the nation breast density inform law in the State of Connecticut (and now, 36 States have breast density legislation).


Disclaimer & Copyright Notice: The materials provided on this website/web-based article are copyrighted and the intellectual property of the publishers/producers (The NY Cancer Resource Alliance/IntermediaWorx inc. and Bard Diagnostic Research & Educational Programs). It is provided publicly strictly for informational purposes within non-commercial use and not for purposes of resale, distribution, public display or performance. Unless otherwise indicated on this web based page, sharing, re-posting, re-publishing of this work is strictly prohibited without due permission from the publishers.  Also, certain content may be licensed from third-parties. The licenses for some of this Content may contain additional terms. When such Content licenses contain additional terms, we will make these terms available to you on those pages (which his incorporated herein by reference).The publishers/producers of this site and its contents such as videos, graphics, text, and other materials published are not intended to be a substitute for professional medical advice, diagnosis, or treatment. For any questions you may have regarding a medical condition, please always seek the advice of your physician or a qualified health provider. Do not postpone or disregard any professional medical advice over something you may have seen or read on this website. If you think you may have a medical emergency, call your doctor or 9-1-1 immediately.  This website does not support, endorse or recommend any specific products, tests, physicians, procedures, treatment opinions or other information that may be mentioned on this site. Referencing any content or information seen or published in this website or shared by other visitors of this website is solely at your own risk. The publishers/producers of this Internet web site reserves the right, at its sole discretion, to modify, disable access to, or discontinue, temporarily or permanently, all or any part of this Internet web site or any information contained thereon without liability or notice to you.

                                    


Friday, May 21, 2021

How this MICRO IMPLANT RADAR revolutionized breast cancer surgeries

 INTRODUCTION

For surgical procedures of breast cancer, NYCRANEWS explores wire-free Radar Localization - a pre-surgical procedure to locate and mark the exact breast abnormality through the use of a small, 12×1.6 mm implanted radar reflector device, roughly the size of a grain of rice. This micro-electronic implant communicates with the scanning handpiece, allowing the surgeon to identify the exact tissue (and how much of it) to extract during a lumpectomy [1]. The early process of localization came in the form of a guide wire insert but later advancements offered other solutions including a wireless radioactive seed and (then) a non-radioactive version called SCOUT®- formerly called SAVI-SCOUT (until July, 2019) [2]. It was developed by Cianna Medical and then acquired in 2018 by Merit Medical, an American medical technology company. 

Publishers of FightRecurrence.com and PinkSmart News dedicated a review of this surgical solution in support of improvements in the preservation of the breast during surgery.  In this feature article, we present Dr. TroyShell-Masouras of Paradise Coast Breast Specialists in Naples Fla. - and David Gilstrap, Director & Global Product Management of Merit Medical. Together, we explored technical perspectives and design strategies behind radar localization and the SCOUT® technology.  They shared the procedural advantages provided by the wire-free upgrade as well as its overall improvements to the patient's well-being in the pre and post-surgical phases.

 

WIRE-FREE UPGRADE IN LOCALIZED IMPLANTS
This segment is from Mr. David Gilstrap's 5/2021 interview.

The concept of SCOUT® wire-free radar localization was developed by Cianna Medical in 2010 and was an alternative to the predominant guide wire concept.  The launch of the SCOUT® introduced "going wire free" for the patient, providing a huge impact on patient satisfaction. Prior to this, the original process included placing a wire in the patient the day of  surgery, and the patient maintains this wire sticking out of their breast until surgery time, which could be up to several hours.

The genesis of the non-radioactive reflector came about in 2010 as the company started re-evaluating the breast surgery localization space, because at the time there were only two other options available;  the guide wire solution (standard for 50+ years) and the radioactive seed alternative. Despite its advantages, the radioactive seed solution showed its own set of limitations and regulatory issues, limiting its public acceptance.  "It needed a lot of training and tracking and was restricted to a limited time where you can actually place it."

By December 2014, Cianna Medical received FDA Clearance for the first generation of SCOUT®  allowing full commercialization in the U.S, and CE Mark for Europe would follow. The implant is technically called the reflector. It doesn't transmit a signal, but actually reflects a signal that's being sent to it. It has its own electronic circuitry, an antenna and it is sealed with a bio-compatible coating called APTEK. There's no power source or moving parts in the reflector- it's inert. With FDA long-term implant status, when it's placed into a patient,  there are no limitations on removal and it can remain in the patient forever. It doesn't have to be removed again. There's no risk to the patient or the area of interest.

Once placed into the region for surgery, the surgeon uses the SCOUT®  surgical guide which transmits pulsating infrared light and a pulsating radar signal (at 50 million pulses/sec). This infrared light activates the reflector which bounces the radar signal back to the system, giving an audible cadence when detected as well as distance measurements from the end of that guide, accurate to one millimeter. To simplify, the technology is very similar to the micro power impulse radar used in your backup sensors in automobiles. So it is very accurate in detecting things over very short distances.

Merit attributes their success in tech feature upgrades to collected end user data from the surgical community. Prototypes are underway for a reduced reflector size, advanced image guidance, customized targeting cadence and improved ease of use in installation  Since SCOUT® is approved for soft tissues it is rapidly expanding into other surgical sites such as pulmonary nodules and soft tissue sarcomas.



Dr. Barry Rosen, breast surgeon at Good Sheppard Hospital (Chicago, IL) describes the many advantages of wire-free localization technology in oncoplastic surgery. For the patient, this innovation adds a new level of ease and adaptability over the traditional (pain and stress of) the wired version.



 

 

 

 





FROM THE SURGICAL FIELD
Breast surgeon Dr. Troy Shell-Masouras expands on the benefits of the wire-free (non-radioactive) radar  in comparison to the former solutions like the localization wire and radioactive seed. This segment is excerpted from Dr. Shell-Masouras' direct interview in 5/2021.

Initially, the first breakthrough into a wireless approach was the radioactive seed - technology that was well-known in prostate cancer. These pellets can be placed into the breast in a similar fashion where the SCOUT reflector would be placed. Once installed, you would use a probe that detects the signal of the seeds. The issue here is that because it is radioactive, there are very strict monitoring and nuclear medicine guidelines on this process as far as its retrieval. To describe this a different way, imagine inserting this radioactive seed in a patient before their surgery-- then if that patient gets into a car accident or disappeared in some way, your entire radioactive seed program could be shut down because you have to be able to retrieve that seed.

There are limitations on how long that seed is active and detectable. Because of these issues, products like SCOUT were developed where there are no limitations on the activity of the device. Time is of no concern if your patient grows ill and their procedure is postponed a month or so down the road. There's no urgency to retrieve the product at any time. These real-life situations are really why products like this are developed.

Comparatively speaking, there appears to be no difference in accuracy between the wired solution, the radioactive seed and the SCOUT. The radioactive seed is significantly smaller than the SCOUT  but this size difference is a non-issue to surgeons. Statements about SCOUT’s (minor) limitations however mention a slight adjustment in work parameters around the distance between the skin and the device particularly with large breasts or very dense breasts. The SCOUT technology is something that continues to evolve... they are trying to develop where you have a different signal if you have more than one lesion from multiple markers within the breast. Merit is also leading to a lot of competition because everybody wants a piece of that wire free action- but the SCOUT developers set the bar pretty high and a lot of institutions have embraced it... I think it's going to be tough for them to break in since SCOUT has already made their mark.

It is noted that programs using radioactive seeds continue to exist, but the market appears to reflect a transition to non-radioactive devices for reasons described.

Dr. TroyShell-Masouras conducts life saving Breast Cancer Surgery at Paradise Coast Breast Specialists in Naples Fla.  Dr. Shell-Masouras specializes in the diagnosis and treatment of breast cancer and benign breast disease, and provides high risk breast cancer assessments, breast ultrasounds, ultrasound-guided breast procedures to include biopsies and aspiration, partial mastectomy and lumpectomy, total mastectomy to include Hidden Scar™ Breast Conserving Surgery and Hidden Scar™ Nipple Sparing Mastectomy, sentinel lymph node biopsy, axillary lymph node dissection, and radar localization for lumpectomies.


VIEWPOINTS

STEPHEN A. CHAGARES, MD FACS- Cancer Surgeon/ General,Laparoscopic, Robotic Surgery -  Yes, the Scout technology is a great progression of technology. It allows accurate localization with site of incision at the Surgeon’s discretion allowing for significantly increased cosmetic appearance of a lumpectomy. Also, it’s placed days earlier so no radiology delays on OR days waiting for patients to return after being sent down for guidewire placement." 

* Opinions expressed in this VIEWPOINTS section are supportive comments about the contents of this article and are solely those from the contributors credited.









The Male Breast Cancer Coalition presented the work of  Dr. Jose Pablo Leone, medical oncologist and researcher at the Dana-Farber Cancer Institute about his research plans covering tamoxifen and aromatase inhibitors for the treatment of male breast cancer.  While women have the benefits of switching to AI should they contract side effects from Tamoxifen, men are in a harder situation when making this decision because not enough data about the efficacy of aromatase inhibitors (AI) are available for men. 

"Currently, only retrospective studies are available out there, which are prone to selection bias. We need to do more research to get scientific validity to dictate treatment for patients.   Due to the physiological differences in the endocrine system between men and women, there may be differences in the efficacy of aromatase inhibitors, leaving men with only Tamoxifen as their primary option.  Tamoxifen for men is the standard recommended drug for men with metastatic breast cancer. If there is progression of disease after Tamoxifen, then other endocrine therapies can be used in the metastatic setting. This is why we need prospective studies evaluating AI in men."  (See complete article)    



BREAST CANCERSCAN NEWS: From the International Oncology Community (Comunit√† Oncologica Internazionale)

4/30/2021 Dr. Robert Bard has been elected as the Sr. Medical Advisor of the Integrative Cancer Resource Alliance- an international community of diagnostic imaging specialists.  His educational presentation has been translated in over 5 different languages for the world stage, supporting partners in The Netherlands, Italy, France and Germany.  This 2021 report recognizes the advancements in non-invasive, real-time diagnostic imaging of cancer tumors for tracking, monitoring, screening and dual diagnosing as well as preop and image guiding intervention during procedures.  Dr. Bard identifies the global movement and demand for virtualization- a medical innovation for remote multi-disciplinary collaboration (ie, TeleRad, Tele-Health and Virtual Conferences) to support the expansion of data sharing  as a modern paradigm of problem-solving in cancer care. 

In an earlier feature, Dr. Bard celebrates the global solidarity of cancer imaging scientists including the work of some of his most respected research colleagues including Professors Luigi Solbiati, Carlo Martinoli, Rodolfo Campani. These are just some of the many highly regarded members of the pioneering community who helped pave the movement for a much improved detection of cancer tumors and other subdermal disorders. 

(Image-L) Once you have a vascular map of the cancer, we have the initial vessel density of 4.5%. Successful treatment over weeks or months will bring it down. In this case, it's down to one quarter of the initial treatment so this is treatment success. This is quantitative mapping of treatment follow-up because if it's working, it's better to change treatment, to avoid the side effects of chemo or other immunotherapies.  The first circle on top shows the red tumor vessels. The 4D Instagram computer reconstruction gives you a quantitative measure of how many tumor vessels are present. Once you have a number, you can follow the number up or down to verify treatment success or failure to adequately adjust treatment that's needed up or down. (For complete review of CLINICAL IMAGING OF BREAST CANCER Explained, visit: breastcancernyc.com)


GET CHECKED NOW! : EARLY DETECTION SAVES LIVES

According to the 
World Health Organization, early detection of cancer greatly increases the chances for successful treatment. In the ongoing battle against cancer, it is common knowledge that most cancers in their early stages are far more likely to be treated with positive results. Moreover, a thorough checkup of one's physiological analyses, heredity review and personal data gathering are all strong info-gatherings for early warning signs that someone may be a candidate for cancer. PROACTIVE tasking starts from AWARENESS, EDUCATION & REGULAR SCREENINGS. The right attitude of self-preservation and an appreciation for longevity is lesson #1. Pursuing a balanced lifestyle covering all the bases of nutrition, exercise, sleep, detoxing and de-stressing is also part of an overall plan for better quality of life. Also visit: www.FightRecurrence.com

 


References:

1) "What is Breast Needle Localization?"  https://myhealth.alberta.ca/Alberta/Pages/Breast-needle-localization.aspx#:~:text=Needle%20localization%20(also%20called%20wire,by%20mammogram%20or%20ultrasound%20guidance.

2) July 2019: "Exciting Changes are Here for SCOUT Radar Localization: Merit medical is excited to announce that SAVI SCOUT will now be known as SCOUT radar localization...  ": https://www.merit.com/wp-content/uploads/2020/07/SCOUT-Report-2019-July-Changes-for-SCOUT-Radar-Localization.pdf

3) Savi Scout- a Surgeon's Perspective (SAVI SCOUT News/ CiannaMedical Newsletter)- https://www.merit.com/wp-content/uploads/2020/09/201808-SCOUTReport-ASurgeonsPerspective.pdf

4) Introducing the New SCOUT Ultrasound Delivery System (SAVI SCOUT News/ CiannaMedical Newsletter)-: https://www.merit.com/wp-content/uploads/2020/09/201812-SCOUTReport-IntroducingTheNewSCOUTUltrasoundDeliverySystem.pdf

5) Seasoned Leader Appointed to Guide / Merit’s Cianna Medical Franchise (SCOUT REPORT-News) https://www.merit.com/wp-content/uploads/2020/07/SCOUT-Report-2019-February-Seasoned-Leader-Appointed-to-Guide.pdf


Disclaimer & Copyright Notice: The materials provided on this website are copyrighted and the intellectual property of the publishers/producers (The NY Cancer Resource Alliance/IntermediaWorx inc. and Bard Diagnostic Research & Educational Programs). It is provided publicly strictly for informational purposes within non-commercial use and not for purposes of resale, distribution, public display or performance. Unless otherwise indicated on this web based page, sharing, re-posting, re-publishing of this work is strictly prohibited without due permission from the publishers.  Also, certain content may be licensed from third-parties. The licenses for some of this Content may contain additional terms. When such Content licenses contain additional terms, we will make these terms available to you on those pages (which his incorporated herein by reference).The publishers/producers of this site and its contents such as videos, graphics, text, and other materials published are not intended to be a substitute for professional medical advice, diagnosis, or treatment. For any questions you may have regarding a medical condition, please always seek the advice of your physician or a qualified health provider. Do not postpone or disregard any professional medical advice over something you may have seen or read on this website. If you think you may have a medical emergency, call your doctor or 9-1-1 immediately.  This website does not support, endorse or recommend any specific products, tests, physicians, procedures, treatment opinions or other information that may be mentioned on this site. Referencing any content or information seen or published in this website or shared by other visitors of this website is solely at your own risk. The publishers/producers of this Internet web site reserves the right, at its sole discretion, to modify, disable access to, or discontinue, temporarily or permanently, all or any part of this Internet web site or any information contained thereon without liability or notice to you.




TUMOR DETECTION FOR DENSE BREASTS

BREAST CANCER DECODED  By:  Robert L. Bard, MD     CONCEPT AND APPROACH Drastic changes in the incidence, diagnosis and treatment of bre...